Testing Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy

NCT ID: NCT07191327

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-09-30

Brief Summary

This study is being completed to learn if high-definition transcranial direct current stimulation (HD-tDCS) has an effect on visual and thinking abilities in persons with posterior cortical atrophy (PCA). Participants will be randomized to receive real or sham HD-tDCS (8 sessions over 4 days).

Following the randomized treatment, participants will have optional open-label phase with real HD-tDCS up to 26 weeks and other possible testing.

Conditions

Posterior Cortical Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real stimulation - Randomized

Four consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.

Group Type: EXPERIMENTAL

HD-tDCS sessions

Intervention Type: DEVICE

This project translates decades of observational neuroimaging research into a biologically plausible stimulation target (i.e., DAN) and uses functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) to plan personalized brain stimulation and to ensure target engagement. When available; those not MRI compatible will receive a standard montage with per channel amplitudes of up to 5 milliamperes (mA) or a montage derived from other imaging methods. Participants will receive 4 days of HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.

Sham stimulation - Randomized

Four consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.

Group Type: SHAM_COMPARATOR

Sham HD-tDCS sessions

Intervention Type: DEVICE

Participants will receive 4 days of sham HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.

Real stimulation - post randomized treatment

Participants that agree to this will have up to 26 weeks of additional HD-tDCS sessions at home or in-person.

Group Type: EXPERIMENTAL

HD-tDCS sessions - Open-label (after randomized treatment)

Intervention Type: DEVICE

Optional 26 weeks of additional HD-tDCS sessions. Participants can complete up to 5 days per week, but most people will complete about 3 days per week. The study team may also collect audio recordings of these sessions. Participants can complete this in person or at-home via using a secure, HIPAA-compliant videoconferencing with the supervision of a research staff member. Participant's that decide to complete the additional sessions at home, a research staff member will train a study partner during the first 4 HD-tDCS sessions in the office. This option may not be available or appropriate for all participants and the study team member will discuss this with participant's and study partners.

Interventions

HD-tDCS sessions

This project translates decades of observational neuroimaging research into a biologically plausible stimulation target (i.e., DAN) and uses functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) to plan personalized brain stimulation and to ensure target engagement. When available; those not MRI compatible will receive a standard montage with per channel amplitudes of up to 5 milliamperes (mA) or a montage derived from other imaging methods. Participants will receive 4 days of HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.

Intervention Type: DEVICE

Sham HD-tDCS sessions

Participants will receive 4 days of sham HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.

Intervention Type: DEVICE

HD-tDCS sessions - Open-label (after randomized treatment)

Optional 26 weeks of additional HD-tDCS sessions. Participants can complete up to 5 days per week, but most people will complete about 3 days per week. The study team may also collect audio recordings of these sessions. Participants can complete this in person or at-home via using a secure, HIPAA-compliant videoconferencing with the supervision of a research staff member. Participant's that decide to complete the additional sessions at home, a research staff member will train a study partner during the first 4 HD-tDCS sessions in the office. This option may not be available or appropriate for all participants and the study team member will discuss this with participant's and study partners.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis or symptoms consistent with PCA
• Fluent in English
• HD-tDCS compatible
• Stable on relevant medications for at least approximately 4 weeks prior to study enrollment
• If completing any additional, optional, long-term study visits in a remote location (i.e., not our office), a study partner is required in order to administer HD-tDCS. Those choosing to return to our office may have, but are not required to have, a study partner.

Exclusion Criteria

• Other relevant neurological disease (e.g., epilepsy) or injuries (e.g., large vessel stroke, moderate-severe traumatic brain injury) viewed as primary to deficits since these could interfere with etiologic considerations and confound study results
• Active, relevant psychiatric conditions (e.g., bipolar disorder, schizophrenia) since the symptoms of these conditions may confound study participation.
• A recent (e.g., within the past 2 years) significant history of, or current, alcohol or drug abuse/dependence. Remote history of abuse/dependence is not exclusionary as long as it is not considered to be the primary etiology for visuospatial deficits.
• Women that are lactating/breastfeeding, pregnant, or may potentially be pregnant will be excluded from the study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Hampstead, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Hamstead, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Schlaefflin, BS

Role: CONTACT

schlst@umich.edu

734-936-7360

Eileen Robinson, RN-BC

Role: CONTACT

robinsoe@umich.edu

734-763-1356

Facility Contacts

Stephen Schlaefflin, BS

Role: primary

schlst@umich.edu

734-936-7360

Eileen Robinson, RN-BC

Role: backup

robinsoe@umich.edu

734-763-1356

Other Identifiers

HUM00268033

Identifier Type: -

Identifier Source: org_study_id